A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex (NCT06924827)
A Clinical Study of the Transition of Children From 'Artisanal' Cannabidiol to Epidiolex
๐ฉบ Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to learn the best way to switch children with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) taking 'artisanal' (non pharmaceutical-grade) cannabidiol (CBD) to Epidiolex for treatment of seizures. The main questions it aims to answer are: * How well does a gradual switch from 'artisanal' CBD to Epidiolex work? * Does the same dose of Epidiolex as 'artisanal' CBD work best? * What side-effects or medical problems do participants have when switching from 'artisanal' CBD to Epidiolex? Researchers will examine how successful switching from 'artisanal' CBD to Epidiolex is. Participants will: * Gradually increase their dose of Epidiolex and reduce their dose of 'artisanal' CBD until they are taking just Epidiolex * Visit the clinic five times over 20 weeks for checkups and tests * Keep a diary of their seizures, symptoms and the number of times they use a rescue seizure medication
Who can join: Review the eligibility criteria below.
Location: The Hospital for Sick Children โ Toronto, Ontario
Age range: 2 Years to 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- The Hospital for Sick Children โ Toronto, Ontario
๐ Contact the Study Coordinator
Phone: (416) 813-7996
Email: laura.macdougall@sickkids.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.